VITROS Performance Verifier II

FDA device recall Z-1373-2024 · posted 2024-03-22 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

Action taken

Consignees were sent an URGENT PRODUCT CORRECTION NOTIFICATION dated 2/27/24 informing them that for product Lot Q1174, diluent Lot M9815 was found in some sales units instead of the expected diluent Lot Q1175, and for product Lot R1176, diluent Lot P9967 was found in some sales units instead of the expected diluent Lot R1177. Consignees were asked to inspect their inventory to see if any mismatched product from affected lots was present and to discard any affected units. The provided Confirmation of Receipt form is to be returned by 3/8/24. Results received using affected devices are to be reviewed for any unexpected QC shift. The recall notification is to be forwarded if any devices were further distributed and the notification maintained in the User Documentation. Customers with any questions can call Global Services at 1-800-421-3311.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJY

Quantity affected

11,224 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal

Date initiated

2024-02-27

Date posted

2024-03-22

Location

Rochester, NY